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New Long-Term HUMIRA(R) (adalimumab) Data Show Up to Seven-Year Efficacy with Combination Treatment for Rheumatoid Arthritis
Date:6/12/2008

PARIS, June 13 /PRNewswire-FirstCall/ -- Seven-year rheumatoid arthritis (RA) data from open-label extension studies show that treatment with Abbott's HUMIRA(R) (adalimumab) resulted in clinical remission among long-standing RA patients when used in combination with methotrexate (MTX). The percentage of patients achieving clinical remission continued to increase after two or more years of continuous treatment with combination therapy. These data were presented at the European League Against Rheumatism (EULAR) annual meeting in Paris.

The seven-year HUMIRA data are a combined analysis of open-label extensions of the ARMADA, DE019, STAR, DE005 and DE037 trials. The open-label extension period of these studies assessed the measures of efficacy, remission and change over time in the safety profile in patients with long-standing RA treated for up to seven years with 40mg of HUMIRA every other week plus MTX.

"Rheumatoid arthritis is a chronic, progressive disease with no cure and usually requires long-term management for patients, so it is reassuring that HUMIRA has demonstrated up to seven years of efficacy in patients with this disease," said Michael E. Weinblatt, M.D., Brigham and Women's Hospital, Boston, and lead investigator.

Seven-Year Clinical Data Summary

A total of 1,469 patients with a history of RA who had continued on from randomized, controlled HUMIRA trials were treated with HUMIRA and MTX for greater than or equal to 30 days and up to seven years in open-label extension studies. The average length of exposure to treatment was 47 months.
The randomized controlled HUMIRA study included:

* The ARMADA trial: a Phase III study to evaluate efficacy and safety

of HUMIRA in patients with moderate to severe RA who had failed at

least one disease-modifying anti-rheumatic drug (DMARD).

* DE019: a Phase III study, which evaluated the efficacy and safety of

HUMIRA in
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SOURCE Abbott
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